Rhee Kyung E, Corbett Takisha, Patel Shamin, Eichen Dawn M, Strong David R, Kang-Sim Eastern, Anderson Cheryl A M, Marcus Bess H, Boutelle Kerri N
Department of Pediatrics, University of California, San Diego School of Medicine, La Jolla.
Herbert Wertheim School of Public Health and Human Longevity Science, University of California, San Diego, La Jolla.
JAMA Netw Open. 2025 May 1;8(5):e258398. doi: 10.1001/jamanetworkopen.2025.8398.
Family-based behavioral treatment (FBT) is recommended for childhood obesity treatment; however, it is not effective for all families. Since parenting training (PT) has been associated with healthy weight and eating behaviors, intensive PT may augment delivery of behavior change strategies and improve child weight loss outcomes.
To compare the efficacy of child overweight or obesity treatment that adds intensive PT to standard FBT with the efficacy of FBT alone.
DESIGN, SETTING, AND PARTICIPANTS: This 2-arm randomized clinical trial (Reinforced, Enhanced, Families, Responsibility, Education, Support, and Health [ReFRESH]) conducted from April 2017 to November 2022 at an academic center in San Diego, California, included children aged 7 to 12 years with overweight or obesity (body mass index [BMI]≥85th to <99.9th percentile) and one of their parents.
Parent-child dyads were randomized 1:1 to the intervention group, which received FBT plus PT, or the control group, which received FBT alone. Both groups received twenty 60-minute sessions over 6 months with separate parent and child groups led by staff and nine 20-minute behavior change coaching sessions. The FBT plus PT group sessions incorporated additional intensive parenting skills training in an interactive format.
The primary outcome was change from baseline in child BMI z score and BMI as a percentage of the 95th BMI percentile (BMIp95) after treatment (month 6) and at 6- and 12-month follow-up. Secondary outcomes included the proportion of children who attained clinically meaningful weight loss (ie, reduction of ≥0.20 BMI z score units) and intervention dropout rates. Intention-to-treat analysis was conducted using linear mixed models and logistic regression.
A total of 140 parent-child dyads were included, with 70 in each treatment arm. Mean (SD) child age was 9.91 (1.54) years, and baseline BMI z score was 2.28 (0.80); 71 children (50.7%) were female. There were no significant between-group differences in BMI z score or BMIp95 after treatment or at the follow-up time points. Both groups had significant decreases in weight status after treatment (combined BMI z score: β, -0.14 [95% CI, -0.21 to -0.07]; P < .001; combined BMIp95: β, -3.46 [95% CI, -5.41 to -1.51]; P < .001). More children in the FBT plus PT arm compared with the FBT arm had a reduction of at least 0.20 BMI z score units (34 [48.6%] vs 22 [31.4%]; P = .01) after treatment (adjusted odds ratio, 2.10 [95% CI, 1.01-4.47]). Both treatments were well accepted, with no between-group differences in risk of dropout (hazard ratio, 1.01 [95% CI, 0.72-1.43]).
In this randomized clinical trial examining the effect of parenting training on child weight status, there were no significant differences in weight status between groups; children in both groups had a significant reduction in weight status. However, more children had clinically meaningful weight loss in the FBT plus PT group. Further work is needed to determine factors associated with treatment response and changes in parenting skills.
ClinicalTrials.gov Identifier: NCT02976636.
基于家庭的行为治疗(FBT)被推荐用于儿童肥胖症治疗;然而,它并非对所有家庭都有效。由于育儿培训(PT)已与健康体重和饮食行为相关联,强化PT可能会增强行为改变策略的实施,并改善儿童体重减轻的效果。
比较在标准FBT基础上增加强化PT的儿童超重或肥胖治疗方法与单纯FBT的疗效。
设计、设置和参与者:这项双臂随机临床试验(强化、增强、家庭、责任、教育、支持和健康[ReFRESH])于2017年4月至2022年11月在加利福尼亚州圣地亚哥的一个学术中心进行,纳入了7至12岁超重或肥胖(体重指数[BMI]≥第85百分位数至<第99.9百分位数)的儿童及其一名家长。
亲子二元组按1:1随机分为干预组(接受FBT加PT)或对照组(仅接受FBT)。两组均在6个月内接受20次60分钟的课程,由工作人员分别带领家长组和儿童组,以及9次20分钟的行为改变指导课程。FBT加PT组的课程以互动形式纳入了额外的强化育儿技能培训。
主要结局是治疗后(第6个月)以及6个月和12个月随访时儿童BMI z评分相对于基线的变化以及BMI占第95百分位BMI(BMIp95)的百分比。次要结局包括实现具有临床意义的体重减轻(即BMI z评分单位降低≥0.20)的儿童比例和干预退出率。使用线性混合模型和逻辑回归进行意向性分析。
共纳入140对亲子二元组,每个治疗组70对。儿童平均(标准差)年龄为9.91(1.54)岁,基线BMI z评分为2.28(0.80);71名儿童(50.7%)为女性。治疗后或随访时间点,两组在BMI z评分或BMIp95方面无显著组间差异。两组治疗后体重状况均有显著下降(综合BMI z评分:β,-0.14[95%置信区间,-0.21至-0.07];P<.001;综合BMIp95:β,-3.46[95%置信区间,-5.41至-1.51];P<.001)。与FBT组相比,FBT加PT组更多儿童在治疗后BMI z评分单位降低至少0.20(34[48.6%]对22[31.4%];P=.01)(调整后的优势比,2.10[95%置信区间,1.01-4.47])。两种治疗方法都很容易被接受,两组在退出风险方面无组间差异(风险比,1.01[95%置信区间,0.72-1.43])。
在这项研究育儿培训对儿童体重状况影响的随机临床试验中,两组在体重状况方面无显著差异;两组儿童的体重状况均有显著下降。然而,FBT加PT组有更多儿童实现了具有临床意义的体重减轻。需要进一步开展工作以确定与治疗反应和育儿技能变化相关的因素。
ClinicalTrials.gov标识符:NCT02976636。